Purpose

To investigate the safety and feasibility of topical injection of bone marrow derived mesenchymal stem cells (BM-MSCs) in acute severe ocular burns.

Methods

In this open-label，single-arm study, subconjunctival injection of allogenic BM-MSCs combined with standard treatment was given to 16 patients with acute severe ocular burns (Dua's grade IV to VI) within 2 weeks after injury. The primary outcome was efficacy rate which referred to the proportion of complete corneal epithelialization patients without perforation. The secondary outcome was safety, visual acuity, the number of symblephara, and elevated intraocular pressure.

Results

One patient was lost to follow-up. During the follow-up period, no corneal perforation was developed. Complete corneal epithelialization was noted 8 (ranged 4–10 weeks) weeks after treatment in 13 eyes (81.3%). The efficacy rate was 87.5% (95% confidence interval, CI: 61.7–98.4). Hypopyon was detected and later well controlled in 1 eye. Partial or total limbal stem cell deficiency (LSCD) was noted in all eyes. Improvement of visual acuity was achieved in 5 out of 16 eyes (31.3%). Seven eyes’ visual acuity was reached 0.1. Symblepharon with varied severity was noted in 5 eyes. Two eyes had elevated intraocular pressure.

Conclusions

This study confirms the safety of subconjunctival injection of BM-MSCs as an innovative and convenient procedure in ocular burns. The overall result is promising considering the absence of perforation, the low severity of symblepharon and visual acuity improvement.

中文翻译：

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结膜下注射间充质干细胞治疗急性严重眼部烧伤的安全性和可行性：一项单臂研究

目的

研究局部注射骨髓间充质干细胞 (BM-MSCs) 治疗急性严重眼部烧伤的安全性和可行性。

方法

在这项开放标签的单臂研究中，16 名急性重度眼部烧伤（Dua 的 IV 至 VI 级）患者在受伤后 2 周内进行了结膜下注射同种异体 BM-MSCs 联合标准治疗。主要结果是有效率，它指的是没有穿孔的完全角膜上皮化患者的比例。次要结果是安全性、视力、眼球突出数和眼压升高。

结果

一名患者失访。随访期间未发生角膜穿孔。在 13 只眼 (81.3%) 治疗后 8（4-10 周）周观察到完全角膜上皮化。有效率为 87.5%（95% 置信区间，CI：61.7-98.4）。在 1 只眼中检测到了低肌层，后来得到了很好的控制。所有眼睛都观察到部分或全部角膜缘干细胞缺陷 (LSCD)。16 只眼中有 5 只眼（31.3%）的视力得到改善。七眼视力达到0.1。在 5 只眼中观察到严重程度不同的 Symblepharon。两只眼睛的眼压升高。

结论

这项研究证实了结膜下注射 BM-MSC 作为一种创新和方便的眼部烧伤手术的安全性。考虑到没有穿孔、symblepharon 的严重程度低和视力改善，总体结果是有希望的。